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June 5, 2011

FDA Accepts Protocol for Study on Marijuana and PTSD

By: Lindsey Stafford

American Botanical Council

The latest edition of the American Botanical Council’s quarterly peer-reviewed journal HerbalGram (Volume 8, Number 6, June 2011) contains a thorough and well-researched article on the FDA’s April 28 approval of MAPS’ planned study of smoked and/or vaporized marijuana for PTSD in veterans of war. The article presents a nuanced summary of the background, rationale, design, and outlook for what could become the first controlled clinical trial of the therapeutic potential of marijuana for PTSD. “I wasn’t surprised with FDA’s favorable review since I have come over the last two decades to respect the FDA’s willingness to put science over politics,” explains MAPS Founder and Executive Director Rick Doblin, Ph.D. “Still, it’s breathtaking every time FDA gives us permission for a new precedent.” Now that the FDA has given the study its stamp of approval, it now falls to the National Institute on Drug Abuse/Public Health Service to decide whether to allow us to purchase the marijuana we need for the study.


Originally appearing at http://cms.herbalgram.org/heg/volume8/06June/MAPS_PTSDprotocol.html.

On April 28, 2011, the US Food and Drug Administration (FDA) accepted a protocol from the Multidisciplinary Association for Psychedelic Studies (MAPS) for studying marijuana and post-traumatic stress disorder (PTSD) in veterans.1 If it obtains the remaining federal government approvals, as well as funding, the study will be the “first controlled clinical trial testing the therapeutic potential of marijuana for treating PTSD.” 

MAPS aims to develop psychedelics and marijuana (cannabis sativa) into prescription medicines that treat conditions for which conventional medicines have provided limited relief. It has wanted to study the effect that marijuana has in patients with PTSD since noticing that more and more veterans were reporting the use of marijuana to treat PTSD symptoms.

“The idea that marijuana could be helpful for PTSD has been around for some time,” said MAPS Founder and Executive Director Rick Doblin, PhD (email, May 17-June 1, 2011). “The reports of the veterans were what drew our attention to our need to learn more about how and in what ways marijuana impacted PTSD patients.”

According to Dr. Doblin, the MAPS research crew spent 8 months designing their study protocol and going through a “friendly but rigorous” critique process for further refining. After submitting to FDA, the organization and government agency were in close communication for 6 months until the recent acceptance announcement.

“I wasn’t surprised with FDA’s favorable review since I have come over the last 2 decades to respect the FDA’s willingness to put science over politics,” said Dr. Doblin. “Still, it’s breathtaking every time FDA gives us permission for a new precedent, like conducting the marijuana/PTSD study as an outpatient study. It means we understand each other’s concerns.”

But before the study can begin, MAPS must obtain additional approval from a protocol review process that exists for no other Schedule 1 drug but marijuana. It is conducted by the Public Health Service (PHS) and the National Institute on Drug Abuse (NIDA)—2 government agencies with reputations for obstructing research on marijuana’s potential medical uses.2


PHS and NIDA Review

All human clinical research using controlled substances must receive approval from the Drug Enforcement Administration (DEA) and permission from FDA to proceed with protocols assessing risks and benefits of an Investigational New Drug (IND). Approval is also required from an Institutional Review Board (IRB), which reviews the protocol and informed consent to protect the rights of the subjects. Only marijuana research proposals must additionally receive scientific merit approval from a PHS/NIDA protocol review committee, after NIDA has signified that it has sufficient cannabis to support the proposed study.2

As a result of the requirement for PHS/NIDA review, researchers encounter a tedious process that often ends in denial or delay.2 While a handful of marijuana research has been approved by PHS/NIDA, several researchers have been denied, often despite FDA and IRB approval of the studies’ designs.

For example, MAPS, California NORML, and a private, DEA-licensed pharmaceutical industry analytical lab, Chemic Labs (Canton, MA), joined in 2003 to study vaporization as an alternative to smoking cannabis. After a 6-year process, PHS/NIDA rejected Chemic’s protocol design—disabling them from obtaining 10 grams (less than half an ounce) of marijuana—and asked the lab to conduct about $60,000 worth of studies to prove the calibration of its instruments—costs that Dr. Doblin has said were not necessary for the pilot study. Due to the frustrating process and unlikely approval, Chemic decided to stop trying to conduct the research.

Due to the PHS/NIDA protocol review procedure, when FDA accepted MAPS’ protocol, it also told the research organization that its IND application would continue to be on clinical hold until it provides information on the chemistry, manufacturing, and controls of NIDA’s marijuana, also known as CMC information.1

“That information is held/owned by NIDA, which will not share it with us unless the PHS/NIDA protocol review committee approves the protocol,” said Dr. Doblin.

MAPS sent its protocol to PHS and NIDA for review on the afternoon of April 28, and has not yet received feedback on timeframes or the identities of the reviewers. “I am starting to think we have a 50/50 chance of the protocol being approved after a fair, scientific evaluation,” said Dr. Doblin. “I’m proud of the design; it’s complex and will generate lots of useful data, and the patients/veterans are a socially powerful group. I expect the process will take about a year—exceedingly slow, compared to FDA, which is required to review protocols within 30 days. After it all, we could easily get rejected.”


Quality and Price of Research Material

If the MAPS protocol is approved by PHS and NIDA, it still is “deeply concerned” about the quality of NIDA’s marijuana, said Dr. Doblin. Published research, in addition to concerns voiced by respected marijuana researchers as well as Dr. Doblin, have stated that NIDA marijuana contained abundant stems and seeds; is dry and often several years old; had thick, pungent, and pervasive smoke; been of inconsistent potency and adversely affected research; and been of “such poor quality” that research could not proceed.2

The organization also has concerns regarding the price of the research material. “I’ve asked NIDA about the expected price about 6 months ago and haven’t heard back,” said Dr. Doblin. “I anticipate about $7—$8 dollar per gram. In large scale medical marijuana production facilities in Israel, production cost is around $1 a gram, [and is] of a much higher quality.”

Additionally, MAPS is also troubled with spending around $10 million on medical marijuana research while being prohibited by NIDA and DEA from producing its own marijuana. Because NIDA retains a monopoly on the production of marijuana for prescription use, it could theoretically charge high prices, with no competition on quality.2


Protocol and Future of Planned Study

The research that MAPS hopes to conduct is a randomized, triple-blind, placebo-controlled, crossover study testing smoked and vaporized marijuana for management of chronic, treatment-resistant, military service-related PTSD in 50 combat veterans.1

Persons who have experienced past traumatic events—childhood abuse, natural disasters, car wrecks—can develop PTSD, which is an anxiety disorder with symptoms such as nightmares, flashbacks and intrusive thoughts and feelings, emotional numbness, sudden anger or fear, and difficulty sleeping.3 Soldiers who have fought in combat often return home with PTSD. For non-military civilians, PTSD occurs in 6-to-10% of the population; for US soldiers who fought in the Iraq War, it was 18%.1 As of 2004, the US government was sending disability payments totaling about $4.3 billion to 215,000 veterans, most of whom fought in the Vietnam War. These numbers and the financial and emotional costs associated with PTSD are expected to continue to rise with the wars in Iraq, Afghanistan, and now, also in Libya.

According to the MAPS’ protocol, THC (tetrahydrocannabinol)—one of the principal active components in marijuana—triggers a response from certain receptors in the hippocampus, amygdala, and prefrontal and anterior cingulate cortex, suggesting that THC is involved in “regulating anxiety, attention to and response to stressful situations, and may be involved in the extinction of conditioned fear.”

While a few therapies, like cognitive behavioral counseling and selective serotonin re-uptake inhibitor drugs, are used to treat PTSD, some patients are not helped by these interventions. MAPS thinks that marijuana treatment might help these types of PTSD sufferers by reducing nightmares and improving sleep and mood.

“Marijuana has the effect of suppressing dream recall,” noted Dr. Doblin. “For people with nightmares, that’s a benefit. Marijuana also helps people focus on the here and now, which reduces the power of the traumas of the past. But, as with all drugs, marijuana isn’t for everyone and some people with PTSD will find that it doesn’t help at all, and can even make things worse. When it works, it’s mostly used on a daily basis that reduces symptoms but doesn’t cure.”

If NIDA and PHS eventually approve MAPS’ protocol, both the study’s lead researcher, Sue Sisley, MD, and the pharmacist working where the marijuana will be stored must obtain a controlled substances license from DEA. According to Dr. Doblin, MAPS would then purchase the marijuana from NIDA, submit the CMC information to FDA, seek approval from an institutional review board, raise funds, and start treating subjects. 

References

1. PROTOCOL MJP-1. IND #110513 Original: November 5, 2010. Amendment 1: March 9, 2011. Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 50 Veterans with Chronic, Treatment-Resistant Posttraumatic Stress Disorder (PTSD).

2. Stafford L. The State of Clinical Cannabis Research in the United States. HerbalGram. 2010;85:64-68.

3. What is PTSD? National Center for PTSD of the United States Department of Veteran Affairs website. Available at: http://www.ptsd.va.gov/public/pages/what-is-ptsd.asp. Accessed May 16, 2011.


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